Food Supplement Registration in Poland - Overview
Poland is an emerging market for food supplements in the European Union (EU), attracting significant interest from industry companies. Food supplements in Poland are governed by the Polish Act of August 25, 2006, implementing Directive 2002/46/EC. Simply classifying food as a food supplement in other markets is insufficient for it to be considered a Food Supplements in Poland or the EU. Compliance with permitted substances, maximum levels, and banned substances in Polish food supplements is crucial. Accurate food labeling, advertising, and health claims verification are necessary to ensure safety and avoid sanctions, product withdrawal, and recalls.
The Chief Sanitary Inspectorate (CSI) serves as the competent authority in Poland. Over the years, the Chief Sanitary Inspectorate (CSI) has issued numerous guidelines and opinions, offering valuable guidance to Food Business Operators (FBOs) regarding the sale, advertising, and regulations of food supplements in Poland. Legislation has also been enacted for botanicals, outlining specific restrictions and conditions of use in the Resolutions of the Food Supplements Team. Maximum levels for vitamins, minerals, and other substances with nutritional and physiological effects are established at the national level.
The Polish market holds particular interest for companies operating in sports nutrition, probiotics, botanicals, and mushroom food supplements Poland. Selling and importing food supplements into Poland, through platforms like Amazon or other e-commerce marketplaces targeting Polish consumers requires compliance with the notification procedure to the Chief Sanitary Inspectorate (CSI). Completion of the notification process results in inclusion on a specific list with a unique registration code.
Notification to the CSI necessitates verification of formula compliance and product labeling. Notably, for a nutrient to be used in food, it must have a significant History of Safe Use (HoSU) within the EU. Failure to meet this requirement classifies the substance as a "novel food", necessitating prior authorization, even if it is solely for use in supplements. Novel food registration occurs at the EU level.
For companies selling food supplements in Poland after Brexit or registered in non-EU countries [including the United Kingdom (UK)], establishing a legal entity in an EU member state or appointing a third-party company as the product's Legal Representative (LR) in Poland or other EU countries is required. This representative must be mentioned on the label, act as the point of contact for the regulatory authority, and establish applicable procedures.
Other food products generally don't require notification in Poland. However, Food for Specific Groups (FSG), such as infant formulas, follow-on formulas, gluten-free foods, and Foods for Special Medical Purposes (FSMP), may require notification. Total diet replacement products for weight control and fortified foods (including sports nutrition products or bars) also fall under CSI supervision. FBOs must ensure compliance with all relevant food regulations in Poland, including composition and labeling.
The dynamic nature of the food market in Poland and the EU requires companies to quickly adapt to Regulatory updates. Freyr, with its operational and delivery center in the EU, offers comprehensive Regulatory support in food supplements registration in Poland to manufacturers, distributors, and other FBOs. Our services encompass Regulatory assessments, food labeling, health claims verification, product notification, Legal Representation (LR), and related procedures such as surveillance and vigilance.
Food Supplement Registration in Poland
Expertise
- Food Product Classification/Food Supplement Classification.
- Formula Review/Ingredients Assessment.
- Safety Assessment of Finished Products/Food Ingredients.
- Label and Claims Review.
- Nutritional and Health Claims Consultation and Substantiation.
- NHCR Claims Application (EU Register on Nutrition and Health Claims).
- Environmental Labeling/Recycling Labeling Review and Review of Green Claims.
- Packaging Material Requirements.
- Dossier Gap Analysis.
- Dossier Compilation and Submission.
- Food Product Compliance.
- Product Notification/Registration.
- EU Country-specific Regulatory Support.
- Regulatory Strategy for the EU.
- EU Legal Representation (LR).
- Regulatory Intelligence (RI) Report.
- Product-specific Updates on the Regulatory Guidelines/Standards.
- Novel Food Authorization Request/Traditional Food from a Third Country Registration.
- Consultation Processes for Determining the Status (novel/not novel) of a Food Ingredient.
- Regulatory Guidance on Food Products/Food Supplements Import Services in the EU.
- Translation Support Services.
- Review of Advertising Promotional Material.
- Food Surveillance and Vigilance.
- Post-notification/Post-marketing Follow-up.
- Management of Alerts and Authorities’ Remarks.
- FBO Registration Support.
- Communication with Health Authorities (HAs).
- Product Compliance for European Economic Area Countries Outside the EU (Switzerland, Norway, and Iceland).
- End-to-end Services for Fortified Foods, Food for Special Medical Purposes (FSMP), Infant Formula, Follow-on Formula, and other Foods for Specific Groups (FSG).
Advantages
- End-to-end Regulatory consultation.
- Market-specific Regulatory consulting and advice.
- Harmonized compliance, local labeling, and local market support.
- Qualified team of experts with hands-on experience across all categories of foods.
- Support for region-specific Regulatory activities.
- Extensive partner network across the globe.
- A strong relationship with various HAs.